OncoMatch/Clinical Trials/NCT06411691
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer
Is NCT06411691 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including KRAS Vaccine with Poly-ICLC adjuvant and Balstilimab for colorectal cancer.
Treatment: KRAS Vaccine with Poly-ICLC adjuvant · Balstilimab · Botensilimab — Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (mCRC) or unresectable or metastatic MMR-p pancreatic ductal adenocarcinoma (PDAC) patients with measurable disease following first-line chemotherapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Colorectal Cancer
Pancreatic Cancer
Biomarker criteria
Required: KRAS one of the KRAS mutations included in the vaccine
Have one of the KRAS mutations included in the vaccine at the time of vaccination expressed in tumor
Required: MMR proficient
MMR-p
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–0(Fully active)
Prior therapy
Must have received: FOLFIRINOX or gemcitabine+nab-paclitaxel (FOLFIRINOX, gemcitabine+nab-paclitaxel) — 1st line metastatic unresectable PDAC
Have received 4-6 months of FOLFIRINOX or gemcitabine+nab-paclitaxel for the 1st line treatment of metastatic unresectable PDAC
Must have received: SOC chemotherapy per NCCN guidelines (FOLFIRINOX, FOLFOX, FOLFIRI +/- targeted therapy with VEGFi or EGFRi) (FOLFIRINOX, FOLFOX, FOLFIRI) — 1st line metastatic CRC
Have received 4-6 months of 1st line SOC chemotherapy per NCCN guidelines (FOLFIRINOX, FOLFOX, FOLFIRI +/- targeted therapy with VEGFi or EGFRi) of metastatic CRC
Must have received: KRAS inhibitor
including prior KRAS inhibitor
Cannot have received: immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4)
Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.)
Lab requirements
Blood counts
adequate organ and marrow function defined by study-specified laboratory tests
Kidney function
adequate organ and marrow function defined by study-specified laboratory tests
Liver function
adequate organ and marrow function defined by study-specified laboratory tests
Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06411691 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapy disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS one of the KRAS mutations included in the vaccine is a required biomarker for enrollment.
Does this trial require MMR?
Yes, MMR proficient is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify